GDUFA Research Outcomes

Human Factors

Research in this area is related to human factors and interactions with the user interface of generic drug-device combination products.

• All(13)
• Posters(1)
• Presentations(11)
• Papers(1)

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly

• Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period

  Hartka, Kathryn

• Closing Remarks

  Lionberger, Robert

• Complex Generic Drug-Device Inhalation Products and User Interface Sameness: Successful Outcomes

  Witzmann, Kimberly

• Considerations for Pre-ANDA Meeting Requests and Case Scenario Setup: Device Constituent of Hypothetical BREATHEATOL Drug Product

  Conti, Denise

• Introduction to Session 4: Device Considerations for Complex Drug-Device Combination Products

  Conti, Denise

• Overview of Complex Generic Inhalation, Nasal and Auto-Injector Drug-Device Combination Products

  Conti, Denise